As part of the Generic Drug User Fee Amendments Reauthorization (GDUFA II) recently agreed with industry , the US Food and Drug Administration (FDA or Agency) has released guidance outlining how sponsors can qualify for shorter review times for priority generics.
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- Progress for Lucentis (ranibizumab) biosimilars in Europe and the US
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- Investigating biosimilar product drift and divergence
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- Switching from adalimumab originator and ABP501 to SB5 in arthritis patients
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